U.S. patent application number 10/897868 was filed with the patent office on 2005-01-06 for radiopaque balloon.
This patent application is currently assigned to SCIMED LIFE SYSTEMS, INC.. Invention is credited to Mistry, Bhavesh, Musbach, Frank A., Sarge, Jeffrey A..
Application Number | 20050004649 10/897868 |
Document ID | / |
Family ID | 25399272 |
Filed Date | 2005-01-06 |
United States Patent
Application |
20050004649 |
Kind Code |
A1 |
Mistry, Bhavesh ; et
al. |
January 6, 2005 |
Radiopaque balloon
Abstract
A stent delivery device which includes a balloon having at least
one radiopaque region or portion.
Inventors: |
Mistry, Bhavesh; (Cupertino,
CA) ; Sarge, Jeffrey A.; (Fremont, CA) ;
Musbach, Frank A.; (Pleasanton, CA) |
Correspondence
Address: |
VIDAS, ARRETT & STEINKRAUS, P.A.
6109 BLUE CIRCLE DRIVE
SUITE 2000
MINNETONKA
MN
55343-9185
US
|
Assignee: |
SCIMED LIFE SYSTEMS, INC.
Maple Grove
MN
|
Family ID: |
25399272 |
Appl. No.: |
10/897868 |
Filed: |
July 23, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10897868 |
Jul 23, 2004 |
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09892048 |
Jun 26, 2001 |
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Current U.S.
Class: |
623/1.11 |
Current CPC
Class: |
A61M 25/10 20130101;
A61M 2025/1079 20130101 |
Class at
Publication: |
623/001.11 |
International
Class: |
A61F 002/06 |
Claims
What is claimed is:
1. A stent delivery catheter comprising: a catheter having a distal
end, the catheter including a balloon near its distal end; a stent
mounted for delivery onto the balloon, the balloon including at
least one radiopaque portion.
2. The stent delivery catheter of claim 1 wherein the radiopaque
portion is made by applying radiopaque ink to the balloon.
3. The stent delivery catheter of claim 1 wherein the radiopaque
portion is made by including radiopaque metal powder in the balloon
material.
4. The stent delivery catheter of claim 1 wherein the at least one
radiopaque portion comprises one or more radiopaque band
portions.
5. The stent delivery catheter of claim 4 further wherein the stent
has proximal and distal ends, and further wherein the two
radiopaque band portions are positioned so that they mark the
proximal and distal ends of the stent.
6. A method of making a stent delivery balloon comprising the steps
of: providing a balloon mold which is etched to make marks on the
balloon; molding the balloon using the provided balloon mold, and
applying radiopaque ink to the balloon portion defined by the marks
made by the etched balloon mold.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] Not Applicable
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH
[0002] Not Applicable
BACKGROUND OF THE INVENTION
[0003] 1. Field of the Invention
[0004] The present invention is directed to a balloon catheter
having at least one radiopaque region. Specifically, the present
invention is directed to a stent delivery catheter in which marker
bands are included on the balloon instead of on the catheter.
[0005] 2. Description of the Related Art
[0006] Stents for transluminal implantation are well known. They
are generally comprised of metallic supports which are inserted
into a part of the human body such as bile ducts, the urinary
system, the digestive tube and notably by percutaneous route inside
the blood vessels, usually the arteries in which case they are
typically termed vascular stents. Stents are usually generally
cylindrical and are constructed and arranged to expand radially
once in position within the body. They are usually inserted while
they have a first relatively small diameter and implanted in a
desired area, for example inside a vessel, then the stent is
expanded in situ until it reaches a second diameter larger than the
first diameter.
[0007] A balloon associated with the catheter is usually used to
provide the necessary interior radial force to the stent to cause
it to expand radially. An example of a balloon expandable stent is
shown in U.S. Pat. No. 4,733,665 to Palmaz, which issued Mar. 29,
1988, and discloses a number of stent configurations for
implantation with the aid of a catheter. The catheter includes an
arrangement wherein a balloon inside the stent is inflated to
expand the stent by plastically deforming it, after positioning it
within a blood vessel.
[0008] Marker bands have been placed on the inner shaft of the
catheter on either side of the stent (which is mounted to the
balloon) to mark the ends of the stent during delivery. However,
placing the marker bands onto the inner shaft of the catheter
requires a crimping step which can result in scraped devices due to
misaligned marker bands.
[0009] U.S. Pat. No. 5,820,585 issued Oct. 13 1998 discloses an
angiographic and arteriographic balloon catheter in which the
proximal and distal ends of the balloon are marked with a
radiopaque print ink. However, this references fails to appreciate
the advantages of a balloon with radiopaque regions for use in
stent delivery.
[0010] The entire content of all of the patents listed within the
present patent application are incorporated herein by
reference.
BRIEF SUMMARY OF THE INVENTION
[0011] Applicants have eliminated the need for marker bands to be
manually crimped onto the inner shaft of the catheter by etching
defined positions onto the balloon itself to indicate where
radiopaque ink material will be sprayed onto the balloon to
function as marker bands on the balloon itself, rather than on the
catheter inner shaft. This eliminates waste due to misaligned
marker bands; reduces the manufacturing cost and reduces device
profile.
[0012] Applicants have invented a balloon catheter which includes a
balloon having at least one radiopaque portion. The radiopaque
portion or region is created by spraying radiopaque ink onto the
balloon where desired. Although any desired portion of the balloon
could be made radiopaque, one embodiment of the invention is to
create two radiopaque marker band regions on the balloon which mark
the ends of the stents mounted on the balloon for delivery.
[0013] Additional details and/or embodiments of the invention are
discussed below.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)
[0014] FIG. 1 is a side cross-sectional view of the inventive
balloon catheter.
DETAILED DESCRIPTION OF THE INVENTION
[0015] While this invention may be embodied in many different
forms, there are shown in the drawings and described in detail
herein specific embodiments of the invention. The present
disclosure is an exemplification of the principles of the invention
and is not intended to limit the invention to the particular
embodiments illustrated.
[0016] FIG. 1 shows a balloon catheter shown generally at 10,
having an outer shaft 12 and inner shaft 14, the inner and outer
shafts forming an inflation lumen. The proximal end of a balloon 16
is connected to outer shaft 10 and the distal end of balloon 16 is
attached to the inner shaft 14. This balloon construction is well
known in the art.
[0017] A stent 18 is mounted for delivery onto balloon 16, as is
well known in the art.
[0018] Radiopaque coating or ink has been sprayed onto balloon 16
in concentric bands shown at 20 and these two radiopaque ink
balloon regions or portions mark or indicate the distal and
proximal ends of the stent. In at least one alternative embodiment,
the balloon 16 may be marked by suspending radiopaque metallic
powder in a resin/solvent mixture which is compatible with the
material of the balloon 16. The mixture may then be painted or
otherwise applied to the balloon surface, after which the solvent
is allowed to flash off. The coating may be comprised of Radiopaque
ink such as may be found in MICROFUSED.TM. radiopaque coatings
available from Implant Sciences Corp. of Wakefield, Mass. Because
the material of the balloon 16 typically will "expand" primarily by
unfolding rather than by stretching, the radiopaque coating or ink
will tend not to peel during balloon 16 expansion.
[0019] In order to locate the desired locations to apply the
radiopaque ink, the balloon mold can be etched to make marks on the
balloon circumference to indicate where the radiopaque ink should
be applied.
[0020] Although radiopaque ink is preferred, radiopaque metal
powder could be used when molding the balloon to create radiopaque
regions.
[0021] Although only two radiopaque bands have been shown, it
should be understood that any desired portion of the balloon could
be made radiopaque using radiopaque ink or metal powder.
[0022] By placing the radiopaque marker bands onto the balloon 16
itself, marker bands can be eliminated from inner shaft 14. This
eliminates a crimping step and potential waste due to marker band
misalignment, making the manufacturing process cheaper.
[0023] This completes the description of the preferred and
alternate embodiments of the invention. Those skilled in the art
may recognize other equivalents to the specific embodiment
described herein which equivalents are intended to be encompassed
by the claims attached hereto.
* * * * *